Overland Park, Kansas 66210

  • Dry Eye Disease

Purpose:

The objectives of this trial are to assess the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).


Criteria:

Inclusion Criteria: - Signed ICF (Informed Consent Form) - Subject-reported history of Drye Eye Disease (DED) in both eyes - Ability and willingness to follow instructions, including participation in all study assessments and visits Exclusion Criteria: - Women who are pregnant, nursing or planning pregnancy - Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control - Clinically significant slit-lamp findings or abnormal lid anatomy at screening and Visit 1 - Ocular/peri-ocular malignancy - History of herpetic keratitis - Active ocular allergies or ocular allergies that are expected to be active during the study - Ongoing ocular or systemic infection - Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study - Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period - Presence of uncontrolled systemic diseases - Presence of known allergy and/or sensitivity to the study drug or saline components - Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening


NCT ID:

NCT04567329


Primary Contact:

Study Director
Daniel Donatello
Bausch & Lomb Incorporated

Margaret Swartzenberg
Phone: (585)338-5327
Email: Margaret.Swartzenberg@bauschhealth.com


Backup Contact:

N/A


Location Contact:

Overland Park, Kansas 66210
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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